苯甲酸利扎曲普坦口腔崩解片的制备及相关评价

Preparation and evaluation of rizatriptan benzoate orally disintegrating tablets

目的制备并评价苯甲酸利扎曲普坦口腔崩解片。方法采取Box-Behnken设计以崩解时限和硬度为考察指标优化苯甲酸利扎曲普坦口腔崩解片处方,考察口腔崩解片在温度(40±2)℃、湿度(75±5)%环境中3个月的稳定性。结果最终确定苯甲酸利扎曲普坦的处方为苯甲酸利扎曲普坦包合物41.35 mg、甘露醇53.19 mg、交联聚维酮6.9 mg、羧甲基纤维素钠7.11 mg、乳糖36.95 mg、滑石粉3.00 mg、硬脂酸镁1.50 mg。结论该工艺较为稳定,可用于苯甲酸利扎曲普坦口腔崩解片的制备。

Objective To prepare and evaluate rizatriptan benzoate orally disintegrating tablets.Methods Box-Behnken design(BBD)was used to optimize the prescription of rizatriptan benzoate orally disintegrating tablets with the disintegration time limit and hardness as reference indicators.The orally disintegrating tablets which were stored at(40±2)℃and(75±5)%for 3 months were investigated.Results The prescription of rizatriptan benzoate orally disintegrating tablets was determined as follows:41.35 mg clathrate compounds,53.19 mg mannitol,6.9 mg crospovidone,7.11 mg carboxyl methyl cellulose sodium,36.95 mg lactose,3.00 mg talcum powder,and 1.50 mg magnesium stearate.Conclusion The process is stable,and the process can be used for the preparation of rizatriptan benzoate orally disintegrating tablets.